Federal Consensus Standards for Medical Devices

October 26, 2014

Federal Consensus Standards for Medical Devices

The Center for Devices and Radiological Health (CDRH), which is a part of the Food and Drug Administration (FDA), is responsible, in conjunction with the Standards Management Staff (SMS), for the development and implementation of both national and international medical device consensus standards. This involves working closely with the Standards Developing Organizations (SDOs) and advertising standards liaison representative positions to maintain an appropriate standards database. SMS publishes updated medical device standards no less than twice annually.

See organizational and contact information for the SMS below or visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm:
organization
Recognized Consensus Standards The FDA’s database of recognized consensus standards can be accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
search-database

 Procedures for the Use of Consensus Standards
The CDHR and SMS believe that conformance to their domestic and international consensus standards ensures the safety and/or effectiveness of a health device. Designers and manufacturers of new health devices can benefit from conformance to these standards since such conformance often eliminates the need to review the test data that applies to the standards when seeking regulatory approval. It should be noted, however, that conformance to the consensus standards will not always be a satisfactory basis for waiving regulatory decisions about a new device.
The CDHR and SMS believe that compliance with their consensus standards represents “the least burdensome approach in all areas of medical device regulation,” but also encourages those who believe an alternative approach would be less burdensome to contact the CDHR Ombudsman at this email address: CDRHOmbudsman@fda.hhs.gov. More information about the office of the Ombudsman can be found at www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.

General Use of Consensus Standards in the Premarket Applications Review Process
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence and, thus, streamline the premarket review process.
Applicants referencing a national or international standard should include a completed Standards Data Form for 510(k)s (FDA Form #3654, Form Approved OMB #0910-0120) as part of their 510(k).

Declaration of Conformity
If a manufacturer decides to conform to one or more recognized consensus standards in its premarket review process for a new device, the manufacturer must submit a “declaration of conformity” to the standards. A manufacturer can use in-house testing or third-party analysis to determine a device’s conformance to consensus standards. The manufacturer is also expected to maintain all records relating to its compliance with the standards.
The FDA recommends that submissions showing a device’s compliance with a consensus standard indicate “yes,” “no,” or “not applicable” for all sections of that standard. Any deviation from the standard should also be clearly indicated.
The FDA states that a declaration of conformity to a recognized consensus standard should do the following:

  • identify the applicable recognized consensus standards that were met
  • specify, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations as described below
  • identify, for each consensus standard, any way(s) in which the standard may have been adapted for application to the device under review, e.g., identify which of an alternative series of tests were performed
  • identify, for each consensus standard, any requirements that were not applicable to the device
  • specify any deviations from each applicable standard that was applied (e.g., deviations from international standards that are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70)
  • specify what differences exist, if any, between the tested device and the device to be marketed and justify the use of test results in these areas of difference
  • provide the name and address of each laboratory or certification body that was involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations, if a test laboratory or certification body was employed

Review of Documentation
When a manufacturer’s declaration of conformity is deemed to conform adequately to FDA-recognized consensus standards, the aspects of the device addressed by the consensus standard are acceptable. There are, however, occasions in which a reviewer may have specific concerns and request additional information from the manufacturer.

Recognition of New and Revised Consensus Standards
To recognize a new standard or a new version of an existing standard, the FDA will post updated information in one of the Supplemental Information Sheets on CDRH's internet page and publish a notice in the Federal Register. The FDA will accept a declaration of conformity to a standard after it is recognized.

Additional Information
Scott Colburn, Director, Standards Management Staff, Office of the Center Director (OCD), is available to answer questions on consensus standards and issues related to declarations of conformity. He can be reached at (301) 796-6287.

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